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Abstract

Background

Foot ulcers are a frequent reason for diabetes-related hospitalisation. Clinical training
is known to have a beneficial impact on foot ulcer outcomes. Clinical training using
simulation techniques has rarely been used in the management of diabetes-related foot
complications or chronic wounds. Simulation can be defined as a device or environment
that attempts to replicate the real world. The few non-web-based foot-related simulation
courses have focused solely on training for a single skill or "part task" (for example,
practicing ingrown toenail procedures on models). This pilot study aimed to primarily
investigate the effect of a training program using multiple methods of simulation
on participants' clinical confidence in the management of foot ulcers.

Methods

Sixteen podiatrists participated in a two-day Foot Ulcer Simulation Training (FUST)
course. The course included pre-requisite web-based learning modules, practicing individual
foot ulcer management part tasks (for example, debriding a model foot ulcer), and
participating in replicated clinical consultation scenarios (for example, treating
a standardised patient (actor) with a model foot ulcer). The primary outcome measure
of the course was participants' pre- and post completion of confidence surveys, using
a five-point Likert scale (1 = Unacceptable-5 = Proficient). Participants' knowledge,
satisfaction and their perception of the relevance and fidelity (realism) of a range
of course elements were also investigated. Parametric statistics were used to analyse
the data. Pearson's r was used for correlation, ANOVA for testing the differences between groups, and a
paired-sample t-test to determine the significance between pre- and post-workshop
scores. A minimum significance level of p < 0.05 was used.

Results

An overall 42% improvement in clinical confidence was observed following completion
of FUST (mean scores 3.10 compared to 4.40, p < 0.05). The lack of an overall significant change in knowledge scores reflected the
participant populations' high baseline knowledge and pre-requisite completion of web-based
modules. Satisfaction, relevance and fidelity of all course elements were rated highly.

Conclusions

This pilot study suggests simulation training programs can improve participants' clinical
confidence in the management of foot ulcers. The approach has the potential to enhance
clinical training in diabetes-related foot complications and chronic wounds in general.

Background

Foot ulcers are a leading cause of hospitalisation for diabetes-related complications
[1]. The vast majority of amputations in the lower limb are preceded by a foot ulcer
[1]. In Australia in 2004/05, for example, the management of people with diabetes-related
foot ulceration required the use of nearly 130,000 hospital beds and contributed to
approximately 3,400 lower extremity amputations and 1,001 deaths [2].

Clinical training is known to have a beneficial impact on diabetes-related foot ulcer
outcomes [3-12]. The authors are not aware of any other clinical training courses that have used
multiple forms of simulation training techniques in the management of diabetes-related
foot complications and/or chronic wounds in general. Simulation has been defined as
a device or environment that attempts to replicate or recreate the real world [13] Simulation training allows the trainer to control the level and complexity of trainee
practice and environmental distractions within a safe, controlled learning environment
[13]. The development of the Foot Ulcer Simulation Training (FUST) program and this pilot
study were seen as a unique opportunity to trial the effectiveness of multiple forms
of simulation training in improving clinical confidence in foot ulcer management.
It is intended that subsequent follow up studies will aim to investigate longer term
impacts on confidence, knowledge, clinical practice and patient outcomes of this program.

Clinician training or continuing medical education (CME) has been described as any
way in which clinicians learn after completion of their formal training [14]. A meta-analysis of CME effectiveness revealed a medium effect size in the change
in clinician knowledge and attitude, and a smaller effect on clinical practice change
and patient outcomes [15]. Importantly, it suggested that larger effect sizes are realised when CME interventions
are interactive, use mixed methods, and are in either small groups or groups from
a single discipline [15]. It has also been reported that CME should focus on Kirkpatrick's four levels of
evaluation: Level I (participant satisfaction), Level II (participant knowledge and
attitude change), Level III (participant clinical practice change) and Level IV (patient
outcomes) [16].

Further results of the CME meta-analysis reinforced the need for CME techniques that
are innovative, interactive and effective [15]. The literature suggests simulation techniques may fit these future CME needs and
outcomes [17].

Patient simulation has been used in the health sector since the 1960s. In the last
two decades the use of simulation in both undergraduate and postgraduate medical and
nursing training has grown prolifically in the acute or inpatient environments [18-20]. However, simulation training for application in the outpatient environment and amongst
allied health disciplines has been a relatively recent development.

The increased uptake of simulation has been driven by several factors including: an
increased focus on patient safety; the community's growing lack of acceptance for
clinicians to acquire skills on real patients; reduction in direct clinical contact
training hours as well as increased patient complexity and demands on healthcare providers
[20-25]. Simulation is not designed to replace conventional teaching methods such as lectures,
tutorials or experience gained through practical clinical exposure, but to be integrated
with established methods to strengthen students' and clinicians' learning experience
[25].

The three main principles that form the foundation of simulation are deliberate practice,
feedback and debriefing or reflection [25]. Deliberate practice is essential in achieving competency in a particular skill.
Simulation provides a safe, controlled environment where participants can develop
skills without fear of adverse clinical consequences whilst being supported by prompt
expert feedback [17,23,25,26] and encouraged to develop skills in reflective practice [22,27,28].

There are several types of simulation that range from web-based interactive and virtual
learning programmes through to full high-fidelity clinical scenario simulation that
is reflective of a participant's work environment. The degree to which a simulation
replicates reality is called "fidelity" [13]. The extent to which a simulation replicates a real-world system, or is realistic,
defines whether they are "high" or "low" fidelity [13]. Each form of simulation has its own uses and learning applications [29]. For this reason, research suggests that simulation courses should aim to incorporate
as many different simulation modalities as possible [30]. The combination of part task trainers (often referred to simply as "part tasks")
and the use of standardised patients (or referred to as "clinical scenarios") are
essential and often under-appreciated as a means of ensuring safe practice and clinical
competency [27]. Part tasks are designed to segment complex jobs or activities into their main individual
components, for example, practicing endotracheal intubation [13]. Clinical scenarios are designed to simulate an entire complex task, for example
the entire emergency management of a motor vehicle accident victim in a simulated
emergency room [13].

Research into different training settings and applications has been positive and supportive
of simulation [31-34]. Overall, the literature has rated highly simulation's ability to improve participants'
technical skills and confidence over the short and long term [31-34]. However, there is a gap in the literature in terms of long-term follow-up investigations
into the translation of skills to improve actual clinical practice and patient outcomes
[35]. From a preliminary review of recent literature, no studies have yet been able to
successfully match course participation with long-term patient outcomes, despite recommendations
in the literature [21,36].

The effective use of simulation to improve participants' confidence and acquisition
of both technical and non-technical skills suggests that its application to the principles
of diabetes-related foot complications or chronic wound care would be advantageous.
The use of non-web-based simulation in Podiatry or diabetic foot management has not
been widely adopted, except in the utilisation of part tasks for single technical
training in basic physical examination, suturing, injection and intravenous techniques,
tissue excision, biopsy and ingrown toenail procedures [37]. A review of the literature identified only training in the single technical skill
of pressure ulcer classification as an application of simulation training in chronic
wound management [38,39].

Moreover, simulation training for application in outpatient settings has rarely been
used [40]. Kneebone et al (2007) recommends expanding the application of simulation training
to any health professional who performs clinical interventions [17]. This is a way of cementing rudimentary clinical skills that are applied in complex
clinical circumstances, as well as in crisis situations [17].

The Foot Ulcer Simulation Training (FUST) course was conceived in 2009 after a Queensland
Health 'training needs analysis' survey of podiatrists prioritised the need to train
podiatrists practically in high risk foot and foot ulcer management as the most important
training need for Queensland Health podiatrists. The course was designed, developed
and implemented in 2010 by the Queensland Health Statewide Podiatry Network and Queensland
Health Clinical Skills Development Service. The primary aim of this pilot study was
to evaluate the impact of a two-day simulation training course on podiatrists' clinical
confidence in the management of foot ulcers. Secondary objectives were to determine
participants' satisfaction with relevance and fidelity (realism) aspects of the course,
and to investigate changes in participants' knowledge.

Methods

Setting and participants

The study was located at the Queensland Health Clinical Skills Development Service
based at the Royal Brisbane and Women's Hospital in Brisbane, Queensland, Australia.
The Clinical Skills Development Service was utilised to help develop and deliver the
FUST training course because of their extensive experience in simulation-based training,
and their international reputation for innovative programs.

The Medical Research Ethics Committee at the University of Queensland, Australia provided
ethical approval for the study. Written informed consent was obtained from all participants
prior to commencement of the course and data collection.

The participants in this study were 16 Queensland Health -employed podiatrists who
voluntarily attended one of two, two-day FUST courses in May or June 2010. Queensland
Health podiatrists were chosen as they are required to prioritise patients with foot
ulcers or high risk feet in accordance with the 'Queensland Health Podiatry Services
Statement of Core Business' (2009), "Queensland Health podiatrists will deliver evidence
based, best practice clinical services for those people with lower limb amputations,
ulcerations, peripheral neuropathy, peripheral vascular disease and/or gross foot
deformities". Therefore, according to Queensland Health podiatry 'core business',
and the aforementioned training needs analysis priority, participation in this training
should have been seen as of being a high priority and benefit for all Queensland Health
podiatrists. Participation was, however, only open to all base level 'clinician' (Level
3 in Queensland Health Practitioner Award) or 'senior clinician' (Level 4) podiatrists
employed by Queensland Health and travel and accommodation was subsidised. An email
alert was delivered to all level 3 and 4 Queensland Health -employed podiatrists inviting
them to register for the courses. A convenience sample was employed as participants
were recruited on a 'first registered, first recruited' basis. The sample of 16 was
nearly half of the total eligible level 3 and 4 podiatrists (35) or one third of the
total 45 podiatry practitioners employed by Queensland Health. Participants were assigned
to one of two course intakes. The first course consisted of eight podiatrists with
fewer than three years of clinical experience or predominantly those at level 3. The
second group consisted of eight podiatrists with three or more years of clinical experience
or predominantly those at level 4. It was assumed that podiatrists with longer clinical
experience or level 4 would have had greater experience in the management of diabetes-foot
related complications and/or chronic wounds.

The course was developed by an advisory committee of 'specialist clinician' (Level
5) and 'consultant clinician' (Level 6) Queensland Health podiatrists in consultation
with endocrinologists and senior simulation co-ordinators. The learning objectives
and content were based upon the clinical skills necessary for 'expert assessment and
management of existing foot ulcer or lesion' as outlined by The National Minimum Skills
Framework for Commissioning of Foot Care Services for People with Diabetes joint report
(United Kingdom, 2006) [41]. 'Specialist' and 'consultant' podiatrists, endocrinologists and a senior simulation
co-ordinator facilitated the courses. The facilitators were trained in their roles
prior to the courses via one day of training and a formal facilitators' manual explaining
all aspects of the course in extensive written and pictorial detail. The practical
training consisted of orientation to the courses simulation equipment and infrastructure,
and practising the facilitation of part tasks, clinical scenarios, debriefing and
other facilitation techniques.

Procedure

Prior to the workshops, all participants were required to ensure completion of a number
of pre-requisite interactive web-based or e-learning modules covering theory on the
management of all types of foot ulcers, approximately five hours in total. At the
beginning of the course, participants were provided with a comprehensive training
manual containing learning objectives, learning resources and detailed written and
pictorial instructions for each aspect of the course.

The FUST program consisted of two days of practical workshop activities. At least
80% of the course time required participants to participate actively in practical
clinical skills or decision-making activities.

The first three sessions of day one consisted of participants practicing foot ulcer
management components or part tasks. Participants were required to complete the practice
of 22 part task "stations". Each part task station encouraged participants to focus
on designated repetitive practice of a particular foot ulcer management component,
for example practicing the performance of toe systolic pressures on subjects. Part
tasks were categorised into six sections, typically consisting of four 10-15 minute
stations per section. Individual stations usually had two participants and one assigned
facilitator. The sections consisted of: high risk foot assessment or comprehensive
non-invasive neurovascular assessments, foot ulcer assessment, infection management,
wound management, off-loading management and multi-disciplinary team work.

The fourth and final session of the first day introduced participants to the "pressure
chamber". This consisted of four rooms in which participants worked in pairs on twenty-minute
scenario rotations designed so as to integrate the individual skills addressed during
the previous part-tasks. Three of the simulated scenarios included a foot model containing
a moulage of a foot ulcer, and a manufactured patient medical history. One room was
a designated debriefing room with a facilitator present. Participants in the three
scenario rooms had the ability to direct any clinical questions to a facilitator observing
behind mirrored glass.

The second day consisted of eight simulated scenarios on a 'controlled' range of standardised
patients (actors) with simulated foot ulcers and/or other diabetes-related foot complications
in a simulated clinical outpatient environment. Additional file 1, Movie file S1 illustrates a short example of a FUST clinical scenario. Two groups
of four participants each participated in parallel clinical scenarios throughout the
day. In each group participants treated the "patient" in pairs for 25-30 minutes whilst
two other participants watched the scenario on live play-back in an adjacent room.
During each scenario a facilitator or endocrinologist would observe behind mirrored
glass and then enter the room to allow participants to perform a case presentation
and to outline their treatment and management plan. As the day progressed the scenarios
increased in complexity.

After each scenario a 15-20 minute debriefing session was held with the participants
in each group who had either actively participated or observed the scenario. The facilitator
was available to provide guidance and offer constructive non-critical feedback, support
and expert advice where required.

Evaluation

The overall evaluation of FUST was multi-layered and consistent with Kirkpatrick's
four levels of analysis, as recommended for CME [17]. However, this paper will only evaluate short term findings of Levels I and II. It
is intended that Levels III and IV will be evaluated in subsequent studies as they
require sufficient time to elapse to enable the measurement of outcomes. Evaluation
consisted of custom-designed surveys to measure participants' course satisfaction
and pre- and post workshop self-rated confidence and knowledge levels in foot ulcer
management. The self-rated confidence and knowledge surveys were distributed to, and
completed by, participants on the morning immediately prior to commencement of the
course and then again at the end of each afternoon and immediately on completion of
the course. To ensure anonymity for participants and the matching of responses, a
four digit code only understood by each individual participant was used for all evaluations.
Participants' clinical confidence was measured across 21 defined foot ulcer management
items, this was a subset of the part tasks and scenarios completed over the two-day
course, using a five-point Likert scale (1 = Unacceptable-5 = Proficient) (Figure
1). Clinical knowledge was measured across seven multiple choice question items (Figure
2). Satisfaction aspects, including relevance and fidelity were also measured using
a five-point Likert scale (1 = Not at all-5 = Completely) (Figure 3).

To gain a more objective view of any change in participants' confidence levels, clinical
supervisors from the participants' work place were also asked to assess the participants'
confidence or competence. The supervisors were asked to complete the same clinical
confidence items and scales as the participants used, with the exception that the
supervisors rated the participants according to the extent that they demonstrated the skills, whereas the participants rated their level of confidence in them. The
supervisors' post workshop survey was not repeated at the conclusion of the FUST course,
unlike the participants' survey. It was necessary for the participants to have time
to apply the skills they learned at the workshop in their workplace, and for their
supervisors to observe and re-assess the participants' competence. It is intended
that follow-up supervisors' surveys will be investigated in subsequent studies.

Statistical analysis

Data were analysed using SPSS 17.0 for Windows (SPSS Inc., Chicago, IL, USA). Although
the data were ordinal in nature, the mean score has been reported as well as the median
in order to give a more refined interpretation of the results. Parametric statistics
were used to analyse the data because there was little difference between the mean
and median scores, and significance levels. Pearson's r was used for correlation, ANOVA for testing the differences between groups, and a
paired-sample t-test to determine the significance between pre- and post workshop
scores for confidence and knowledge. The decision to use parametric statistics in
the study is supported by recent literature that provides strong evidence of the robustness
of parametric statistics when used, inter alia, with Likert scales and data with non-normal distributions [42,43]. A minimum significance level of p < 0.05 was used throughout.

Results

All 16 participants had completed the pre-requisite web-based modules. Of the 16 participants
who commenced FUST, 15 completed the workshop. One participant in the first group
failed to complete the course due to illness unrelated to the FUST course and was
unable to complete the post-workshop surveys. The pre-workshop data from the participant
that failed to complete the course has been retained in this study.

No statistically significant difference was detected between scores from podiatrists
with different levels of experience except on one clinical confidence item and one
fidelity item. Podiatrists with more than three years experience reported a greater
increased confidence in their ability to refer patients appropriately for hyperglycaemic
management, and also greater task fidelity in the off-loading part task than those
with less experience.

Satisfaction

Overall satisfaction with the course was high. Of the 14 out of 15 participants who
completed the question on the post workshop survey (one did not record a response
to that question), 13 rated the course as being 'excellent' and one as being 'very
good'. All participants reported that they had met their objectives for attending
FUST 'completely', that the level of the workshop was 'just right', and that the variety
in workshop delivery was sufficient.

One hundred percent of participants rated the quality of facilitators as being "excellent"
(five out of five for all items). Furthermore, lectures provided during the workshop
received a median score of five out of five (mean score range 4.67 - 4.73) on all
items including: preparing participants for practical session; being pitched at the
right level and relevant to work; holding participants' interest and teaching them
something that they did not know previously.

Relevance and fidelity (realism)

Overall, the mean scores for relevance and fidelity were respectively 4.82 and 4.47
out of 5.

Clinical knowledge

There were seven knowledge items assessed before and after the workshop. Only one
item, 'determining if an ischaemic ulcer requires vascular surgical referral', recorded
a statistically significant improvement (p = 0.009). Table 1 shows all knowledge items and scores.

Clinical confidence

Participants' clinical confidence was observed to have improved 42% overall between
pre- and post-completion of FUST, with respective mean scores of 3.10 compared to
4.40 (p < 0.05). Figure 4 demonstrates the statistically significant (p < 0.05) improvement in participants' confidence levels across all 21 clinical items.
Improvements ranged from 17% for ability to refer for hyperglycaemia management, to
100% for ability to apply a Removable Cast Walker. Additionally, Table 2 shows that regardless of their level of experience, all groups had a similar statistically
significant improvement in their confidence levels following the course (p < 0.05).

Table 2. Comparisons of overall pre- and post workshop scores for confidence by years of clinical
experience

Ten participants had supervisors who completed and returned the parallel supervisors'
survey of participants' confidence levels across the twenty-one items. The other five
participants did not have a podiatry clinical supervisor, and therefore, could not
be rated by a supervisor. There were statistically significant differences (p < 0.05) in the scores for only six of the twenty-one items which were: definition
of foot ulcer types; appropriate debridement of non-viable tissue; correct measurement
of foot ulcer dimensions; measurement of infected tissue; accurate recording of infected
tissue; interpretation and classification of infected tissue.

Discussion

The majority of published studies have focused on simulation training's impact in
an emergency, trauma or surgical environment [31-35,40,44-46]. This study was unique in that it suggests improved clinical confidence of participants
after using simulation training techniques related to the management of diabetes-related
foot complications and/or, chronic wounds, in this case foot ulcers. The success of
this pilot study supports suggestions that simulation is flexible enough to lend itself
to multiple clinical training environments, disciplines and needs [21,26,47-49]. Additional advantages of simulation training in healthcare include its ability to
allow participants the opportunity to develop, practice and integrate technical and
non-technical skills [21,27,29,47,48].

The developers of the FUST course adopted a mixed method course design, as described
and recommended by other best-practice CME programmes [15], and applied them to clinical training in outpatient diabetes-related foot complications
and chronic wounds. These CME principles included the use of interaction (at least
80% of the time) and mixed methods (case studies, numerous low-fidelity part tasks,
high-fidelity full clinical scenarios, and regular non-judgemental debriefing exercises)
in small single-discipline groups (of eight podiatrists per course) [15]. FUST also incorporated the simulation principles of deliberate practice, feedback
and debriefing [25].

The FUST course avoided the common mistake of some simulation programmes of directly
replacing conventional teaching methods with simulation techniques [25]. Completion of web-based learning modules was a pre-requisite to the workshop and
provided the conventional theoretical foundation for the practical two-day FUST course.
Brief lectures were also integrated into the workshop to summarise the theory before
practical interactive tasks were commenced.

Participants' overall satisfaction was high and reflected the course's integration
of best practice CME and simulation principles. Participants had their learning needs
met completely, and importantly, felt the variety in course delivery was sufficient
and pitched at just the right level.

The importance of appropriate training in the facilitation of FUST was evidenced in
the participants' positive rating of the facilitators who provided a safe and non-judgemental
environment where participants could practice new techniques and receive timely and
structured feedback [21,26,29,47-49]. All participants reported that the facilitators had created an environment where
attendees were encouraged to participate, ask questions, and where the facilitators
had demonstrated the expected behaviour. Additionally, a number of participants suggested
that participating in the course "was fun" which is in line with adult learning principles
that "fun and enjoyable" training enhances the effectiveness of learning [50].

Deficits in realism and fidelity are commonly reported limitations with manikins and
the use of actors in standardised patient scenarios who lack the clinical knowledge
to accurately reflect a clinical situation [18,27,29,49]. However, it is notable that the participants in this study rated highly the relevance
and fidelity of their interactions with the eight clinical scenarios. This may be
partially attributed to the use of experienced clinicians to act as patients in clinical
scenarios, as well as the realistic look and feel of the foot models. Arguably, the
clinician actors were able to provide more flexible and realistic clinical responses
than those confined to a predetermined script. The perceived high level of relevance
and fidelity suggest that FUST meets the CME criteria for innovation and interactivity
[15]. The formal curriculum, learning objectives, detailed instruction manuals, practical
training of facilitators, and the use of standardised part task trainers, and a range
of standard clinical scenarios should ensure the standardised high quality delivery
of FUST in most clinical training environments.

Simulation training in healthcare is consistently rated by participants as a highly
effective and enjoyable education medium [48,51]. The FUST course was no exception. Although, this appears to indicate a successful
course on its own, the literature suggests that Level I CME ratings are a poor indicator
of clinical effect. Direct analysis of Level II clinical knowledge, attitudes and
skills at least is required to determine the impact on clinical practice and patient
outcomes [15].

Minimal improvement was recorded in clinical knowledge as pre-course test scores were
already high. This "ceiling effect" (when scores are close to the highest they can
be) [52] was somewhat expected given that participants' had existing high levels of clinical
involvement and interest in the area and the pre-requisite completion of learning
theory via web-based modules in the months prior to attending the course. However,
the course should have served to reinforce the participants' learning from the detailed
manual and the learning resources provided.

All participants' confidence levels rose significantly in all the areas covered by
FUST, regardless of their years of podiatry experience. One may infer from these results
that doing a workshop such as FUST is worthwhile even for experienced podiatrists,
as it provides the opportunity to refresh skills and consolidate a clinician's understanding
of foot ulcer management. This particular confidence improvement was only measured
over the short term. However, other simulation studies have demonstrated longer term
confidence retention following short-term confidence improvements compared to conventional
training [48].

The supervisors' assessment of the participants' pre-FUST competence in the skills
covered by the workshop aligned with participants' own confidence ratings. Supervisors'
results indicate that the collective participants' pre-test or baseline confidence
or competence was only adequate, rather than competent or proficient. Similarities
in the ratings provided by participants and supervisors indicate that participant
ratings were relatively objective and not unduly affected by self-report bias. Subsequent
long-term follow up of both participants and supervisors, in future research, will
provide a clearer picture.

A large body of evidence exists in support of simulation's ability to increase participants'
confidence [53]. Increased confidence levels have been associated with self-efficacy and higher rates
of participants actively seeking opportunities to further develop newly acquired skills
[36,53]. Self-efficacy is an important outcome from any training program as it reflects participants'
ability to translate acquired skills into day-to-day clinical practice [36,54]. Evaluating participant confidence levels is also consistent with Kirkpatrick's four
levels of evaluation, and supported the rationale behind its inclusion in this pilot
study [16].

Three potentially significant methodological limitations existed in this study. Firstly,
the sample size was small. However, with the promising results of this pilot study
it can be recommended that larger studies with greater numbers be undertaken.

A second limitation was the absence of a matched control group. This was partially
addressed, by using matched participant and supervisor pre-workshop scores as a baseline
comparator. It is recommended in future larger studies that a control group is included.
Furthermore, this serves to highlight another limitation of potential investigator
bias; five of the ten returned pre-intervention supervisor surveys were from supervisors
who were either investigators or facilitators of the impending FUST course. This limitation
is likely to have been minimised as the study's information sheet recommended supervisors
and participants use the supervisors' ratings as part of their participants' annual
formal Queensland Health 'Performance Appraisal' to maximise objectivity of this item
from supervisors.

Thirdly, performing the pre-knowledge test after the theoretical web modules were
completed may have been a limitation. The literature strongly suggests the need for
conventional lectures as a theoretical foundation to complement the simulation practice
[25]. It was decided to use the existing web-based professional development modules already
developed for Queensland Health clinicians as the conventional lecture component.
These modules had been recommended to Queensland Health podiatrists as a professional
development component of their performance appraisals for at least 12 months prior
to the conception of this study. Thus, the imparting of this knowledge was unable
to be controlled in this study. Other simulation studies have also found the timing
of pre-knowledge tests to fit conventional lectures challenging, and have followed
similar methodology to FUST in this regard [48].

Other perceived limitations of this study included potential bias in recruiting subjects
with a low level of high risk foot knowledge and clinical confidence because this
may have over inflated any effect size. The investigators believe this limitation
was minimised by the selection of participants that work predominantly with patients
with diabetes-related foot complication and chronic wounds as per the aforementioned
Queensland Health Podiatry Services Statement of Core Business (2009). However, again
with the promising results of this pilot study's impact on participants with sound
existing levels of high risk foot confidence and knowledge, further studies investigating
the impact on participants with low levels of existing high risk foot knowledge and
clinical confidence would be recommended.

Simulation training is highly facilitator-intensive and its cost is a commonly cited
disadvantage [27,29,48,49]. Cost-benefit analyses of simulation programs are needed to justify their expense
in terms of improved clinical performance and patient outcomes. Another barrier to
wider implementation is the lack of evidence to support the translation of simulation-acquired
skills into actual clinical practice and improved patient outcomes [27,29,48,49]. Reasons for this shortfall in research include the difficulty of establishing causality
and related methodological issues such as obtaining sufficiently large sample sizes
for long-term follow up [26,36].

Conclusion

FUST is the first pilot study to investigate the use of mixed modality simulation
training techniques in the management of diabetes-related foot complications and/or
chronic wounds. The FUST study has shown proof of concept for the use of simulation
in foot ulcer management training. It supports the commonly-cited hypothesis that
simulation is effective in generating participants' interest whilst facilitating repetitive
and reflective practice. The study has demonstrated the potential to improve clinicians'
confidence, knowledge and satisfaction in the management of foot ulcers through an
integrated simulation-based training program. Clinical training literature suggests
increased clinical self-confidence contributes positively to improved patient outcomes.
Larger prospective studies using foot ulcer simulation clinical training programs
are recommended to investigate participants' confidence, knowledge, clinical practice
and patient outcomes, such as hospitalisation and amputation rates.

List of Abbreviations

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

PAL conceived, designed, researched data, contributed to discussion, wrote and reviewed/edited
the manuscript. ELM researched data, contributed to discussion, wrote and reviewed/edited
the manuscript. PMR designed, researched data, contributed to discussion and reviewed/edited
the manuscript. FMB contributed to discussion, wrote and reviewed/edited the manuscript.
SJ, EMK and GMP designed and reviewed/edited the manuscript. MCK conceived and reviewed/edited
the manuscript. All authors have read and approved the final manuscript.

Acknowledgements

The authors acknowledge significant funding and support from the Queensland Health
'Allied Health Clinical Education and Training Unit', 'Clinical Skills Development
Service' and 'Podiatry Network'. The authors also acknowledge the significant contribution
made to operating the FUST project by the following individuals: Ms Madeline Avci,
Ms Rebecca Mann, Mr Damien Clark, Ms Kerrie-Anne Frakes, Dr Grant Cracknell and Dr
Peter Thomas. All contributors are affiliated with one of the aforementioned funding
and support bodies. None of these contributors have a relevant conflict of interest.
Lastly, the authors thank Molnlycke Health Care and Vasyli Medical for their kind
donation of wound dressings and insoles respectively.

References

Australian Centre for Diabetes Strategies: Identification and management of diabetic foot disease, in National evidenced based
guidelines for the management of Type 2 Diabetes Mellitus. Diabetes Australia Guideline Development Consortium Sydney; 2005.